Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The FDA announced today that Bayer Pharmaceuticals Corp. will begin removing all remaining supplies of the drug Trasylol (aprotinin) from warehouses and other medical stock. The decision comes following the preliminary results of a test that showed the drug greatly increased the risk of death. Trasylol is administered to patients undergoing heart surgery to slow bleeding and reduce or eliminate the need for blood transfusions.

Beginning immediately, Trasylol will belong to a class of drugs that require a special protocol for use. Patients who are at a high risk for blood loss during coronary artery bypass graft surgery may receive Trasylol if no alternative therapies are appropriate. In such cases, physicians must follow a special treatment protocol and submit it to the FDA for approval. The physician must show that the benefits of administering Trasylol outweigh the risks.

Trasylol is an antifibrinolytic drug that reduces excessive bleeding by slowing the breakdown of blood clots during heart surgery. In October 2007, the Data Safety Monitoring Board (DSMB) recommended the discontinuation of patient enrollment in a randomized Canadian study of aprotinin. The study was stopped once data suggested an increased risk of death in patients who had received Trasylol.

The FDA will reassess its special treatment protocol for Trasylol once it receives and has reviewed data from the study’s researchers. According to the FDA’s statement, “the FDA oversight requires comprehensive and thorough studies of a drug not only during the pre-market review phase but throughout the drug’s life cycle.” Many critics of the FDA object to the administration’s method of drug approval, which, they argue tests effectiveness of new medicines but not safety.

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